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Completed

NCT Number: NCT01257217

A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)

The purpose of this study is to evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Presbyopia Refractive Errors

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1 and Month 3 after the second implantation). The second implantation occurred within 30 days of the first.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sign informed consent;
  • Able to attend postoperative examinations per protocol schedule;
  • Diagnosed with bilateral cataracts;
  • Planned cataract removal by phacoemulsification with implantation of an intraocular lens (IOL);
  • Preoperative astigmatism ≤ 2.5 diopter;
  • Good ocular health, with the exception of cataracts;
  • Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and Acri.LISA package inserts;
  • Able to undergo second eye surgery within one month of the first eye surgery;
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Previous corneal surgery;
  • Planned multiple procedures during cataract/IOL implantation surgery;
  • Any ocular disease and/or condition that may compromise study results;
  • Pregnant or planning pregnancy during course of study;
  • History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
  • Diabetic retinopathy;
  • Macular degeneration;
  • History of retinal detachment;
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1

Device

Multifocal IOL implanted for long-term use over the lifetime of the cataract patient

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT

Device

Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient

Other names: Models SND1T2, SND1T3, SND1T4, SND1T5, SND1T6

Acri.LISA® 366D IOL

Device

Aspheric diffractive IOL with +3.75 D add power implanted for long-term use over the lifetime of the cataract patient

Acri.LISA® 466TD Toric IOL

Device

Aspheric diffractive IOL with +3.75 D add power and astigmatism correction implanted for long-term use over the lifetime of the cataract patient

Primary outcomes

  1. Mean Binocular Defocus VA at Month 3

    Time frame: Month 3 from second eye implantation

    Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

Secondary outcomes

  1. Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3

    Time frame: Month 3 from second eye implantation

    Visual acuity (VA) was tested binocularly (both eyes together) with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

  2. Uncorrected Visual Acuity Across a Range of Distances at Month 3

    Time frame: Month 3 from second eye implantation

    VA was tested binocularly unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

  3. Mean Refractive Spherical Equivalent at Month 3

    Time frame: Month 3 from second eye implantation

    A manifest refraction (vision check) was performed using a 100% contrast ETDRS chart under well-lit conditions. Results were documented for sphere, cylinder and axis readings. The refractive spherical equivalent was calculated according to the formula: sphere + ½ cylinder power. Both eyes contributed to the mean.

  4. Mean Radner Reading Speed

    Time frame: Month 3 from second eye implantation

    Reading performance was measured using the Radner Reading Chart with no correction (without) and with best distance corrective aids (with). Reading speed was measured in words per minute.

  5. Patient Reported Outcomes at Month 3

    Time frame: Month 3 from second eye implantation

    The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Tasks were rated using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A Randomized, Subject-Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting IOLs

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 9, 2010
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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